A Study Evaluating Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine

Chronic Migraine Clinical Trial

Official title:

A Phase 3, Multicenter, Open-Label 52-Week Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04437433
• Other study ID #: 3101-306-002
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 18, 2020
• Est. completion date: June 14, 2024

Study information

• Verified date: April 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the long-term safety, efficacy and tolerability of atogepant 60 mg daily for the prevention of migraine in Japanese participants with chronic or episodic migraine.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 186
• Est. completion date: June 14, 2024
• Est. primary completion date: June 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

3101-303-002 Completers:

• Eligible participants who completed Visit 7, and Visit 8 if applicable, of the Study 3101-303-002 without significant protocol deviations and who did not experience an adverse event (AE) that, in the investigator's opinion, may indicate an unacceptable safety risk.

De Novo EM Participants:

• Age of the participant at the time of migraine onset < 50 years.
• At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3, 2018.
• History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1 in the investigator's judgment.
• 4 to 14 migraine days in the 28-day baseline period per eDiary.
• Completed at least 20 out of 28 days in the eDiary during baseline period and is able to read, understand, and complete the study questionnaires and eDiary per investigator's judgment.

Exclusion Criteria:

• Requirement for any medication, diet, or nonpharmacological treatment that is on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative medication or treatment.
• Participants with an ECG indicating clinically significant abnormalities at Visit -1 (De Novo Episodic Migraine Participants) or Visit 1 (3103-303-002 Completers).
• Hypertension as defined by sitting systolic BP > 160 mm Hg or sitting diastolic BP > 100 mm Hg at Visit 1.
• Significant risk of self-harm based on clinical interview and responses on the (Columbia-Suicide Severity Rating Scale [C-SSRS]), or of harm to others in the opinion of the investigator.
• Any clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

De Novo EM Participants only:

• Difficulty distinguishing migraine headaches from tension-type or other headaches.
• Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine as defined by ICHD-3, 2018.
• Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3, 2018.
• Has >= 15 headache days per month on average across the 3 months prior to Visit 1 in the investigator's judgment.
• Has >= 15 headache days in the 28-day baseline period per eDiary.
• Usage of opioids or barbiturates > 2 days/month, triptans or ergots >= 10 days/month, or simple analgesics >= 15 days/month in the 3 months prior to Visit 1 per investigator's judgment or during the baseline period.

Related Conditions & MeSH terms

• Chronic Migraine
• Episodic Migraine
• Migraine Disorders

Intervention

Drug:
• Atogepant 60 mg
Tablets containing 60 mg atogepant

Locations

Country	Name	City	State
Japan	Niwa Family Clinic /ID# 232713	Chofu-shi	Tokyo
Japan	Fukuiken Saiseikai Hospital /ID# 232988	Fukui-shi	Fukui
Japan	DOI Internal Medicine-Neurology Clinic /ID# 232722	Hiroshima
Japan	Hiroshima Neurology Clinic /ID# 232720	Hiroshima
Japan	Saitama Medical University Hospital /ID# 233017	Iruma-gun	Saitama
Japan	Duplicate_Tokai University Hospital /ID# 233071	Isehara-shi	Kanagawa
Japan	Tanaka Neurosurgical Clinic /ID# 232884	Kagoshima
Japan	Atsuchi Neurosurgical Hospital /ID# 232907	Kagoshima-shi	Kagoshima
Japan	Nagaseki Headache Clinic /ID# 232719	Kai-shi	Yamanashi
Japan	Fujitsu Clinic /ID# 232717	Kawasaki-shi	Kanagawa
Japan	Konan Medical Center /ID# 232922	Kobe-shi	Hyogo
Japan	Umenotsuji Clinic /ID# 232675	Kochi-shi	Kochi
Japan	Tatsuoka Neurology Clinic /ID# 232912	Kyoto
Japan	Takanoko Hospital /ID# 232723	Matsuyama-shi	Ehime
Japan	Mito Kyodo General Hospital /ID# 232990	Mito-shi	Ibaraki
Japan	Tominaga Hospital /ID# 232909	Osaka
Japan	Saitama Neuropsychiatric Institute /Id# 232711	Saitama-shi	Saitama
Japan	Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 232710	Sapporo-shi	Hokkaido
Japan	Sendai Headache and Neurology Clinic Medical Corporation /ID# 232677	Sendai-shi	Miyagi
Japan	Tokyo Headache Clinic /ID# 232715	Shibuya-ku	Tokyo
Japan	Duplicate_Dokkyo Medical University Hospital /ID# 232995	Shimotsuga-gun	Tochigi
Japan	Keio University Hospital /ID# 233030	Shinjuku-ku	Tokyo
Japan	Japanese Red Cross Shizuoka Hospital /ID# 232992	Shizuoka-shi	Shizuoka
Japan	Shinagawa Strings Clinic /ID# 232908	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with at Least 1 Treatment Emergent Adverse Event		Across the 52-week treatment period
Secondary	Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator		Across the 52-week treatment period
Secondary	Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator		Across the 52-week treatment period
Secondary	Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator		Across the 52-week treatment period
Secondary	Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales	A clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior)	Across the 52-week treatment period

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